GlaxoSmithKline Ebola vaccine shows safety in PhI
|Ebolavirus under an electron microscope--Courtesy of CDC|
The most recent Ebola epidemic may have wound down, but the race for a vaccine is far from over. GlaxoSmithKline's ($GSK) experimental Ebola jab, which was taken to Phase I in the U.S. and Mali last October, was well-tolerated and elicited strong immune responses in adults.
The vaccine was tested in a single-blind, randomized trial involving 20 adults aged 18 to 65 in Baltimore. The Phase Ib dose-escalating trial involved 91 adults aged 18 to 50 in Bamako, Mali. Some of the Bamako volunteers were given a booster shot, manufactured by Rockville, MD's Emergent BioSolutions ($EBS).
The study, published in The Lancet Infectious Disease, was carried out by researchers from the Center for Vaccine Development at the University of Maryland School of Medicine. The study found no safety concerns, according to a University of Maryland statement. Further studies--some of which are already underway--were recommended.
"Ebola remains an urgent international public health problem. Dr. [Myron] Levine and the CVD team have done excellent work with this study. It will give us crucial data that will eventually help those who are on the front lines of the fight against Ebola," said School of Medicine Dean Dr. E. Albert Reece in the statement.
Glaxo has tested the vaccine in Phase I in Bethesda, MD, is testing it in Phase II in Senegal and Phase III in Liberia. In May, the British pharma teamed up with Emergent to test its jab with the latter's vaccine as a booster.
Meanwhile, Profectus BioSciences, also based in Maryland, is developing a trivalent Ebola vaccine, which has proven effective in monkeys and could be ready for human trials by mid-2016, The Baltimore Sun reported. And competitor NewLink ($NLNK), which is working in tandem with Merck ($MRK) on a jab that posted 100% efficacy in a novel "ring study" recently won $26 million in government funding, while Johnson & Johnson ($JNJ) scored a $28.5 million BARDA partnership to advance its candidate.
Because the Ebola epidemic has waned over the past year and there aren't enough Ebola cases to test the efficacy of experimental vaccines against actual Ebola infection, the FDA is considering alternate approval pathways for Ebola vaccines.
- read the University of Maryland release
- here's the study abstract
- read more from The Baltimore Sun
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